Particle.news
Download on the App Store
3 ARTICLES
·
2h ago

FDA Requests Removal of Suicide Warnings From GLP-1 Weight-Loss Drugs

The move follows an FDA analysis of 91 placebo-controlled trials showing no increased psychiatric risk.

FILE - Boxes for the medications Wegovy and Zepbound are arranged for a photograph in California, May 8, 2025. (AP Photo/JoNel Aleccia, File)

Overview

  • The request covers widely used weight-loss medicines, including Novo Nordisk's Wegovy and Saxenda and Eli Lilly's Zepbound.
  • The review pooled data from 91 randomized, placebo-controlled trials with 107,910 participants.
  • Analyses found no increase in suicidal thoughts or behavior compared with placebo and no signal for anxiety, depression, irritability, or psychosis.
  • The decision updates a 2024 preliminary review that had not ruled out a small risk due to limited data.
  • Novo Nordisk and Eli Lilly did not immediately respond to requests for comment on the label change.